The impact of alternate HPV vaccination and cervical screening strategies in Japan: a cost-effectiveness analysis.

Background: The Japanese 2020 cervical screening guidelines recommend conventional cervical cytology screening every 2-years for women aged 20-69 years. The nonavalent human papillomavirus (HPV) vaccine has also recently been approved in Japan. We therefore evaluated the cost-effectiveness of cervical cancer screening strategies alongside universal nonavalent HPV vaccination of girls (12-16 years). Methods: A cost-effectiveness analysis was performed using an age-specific Markov microsimulation model for Japan to evaluate total costs, quality adjusted life-years (QALYs) gained, incremental cost-effectiveness ratios (ICER), colposcopies, biopsies, precancer and cervical cancer treatments for 29 combined vaccination and screening strategies (conventional cytology, liquid-based cytology (LBC), HPV testing, and HPV self-collection). A cohort of 100,000 girls (12-16 years old) over a lifetime offered the nonavalent HPV vaccine was used (current vaccination coverage = 0.08%, current screening coverage = 43.7%). A discount rate of 3% was applied to costs and QALYs. Univariate and probabilistic sensitivity analysis was performed to assess robustness of the findings. Costs were reported in US dollars (2023). Findings: Compared with conventional cytology, evaluated strategies would incur an additional cost of US$839,280-738,182,669 and gain 62,755-247,347 quality-adjusted-life-years. HPV testing distinguishing HPV16/18 with reflex LBC (3-yearly) would be most cost-effective (ICER = US$7511 per QALY gained). At a willingness-to-pay (WTP) of 1-times gross domestic product (GDP) per capita, the probability of it being cost-effective was 70%. At historically high vaccination coverage (70%) ICERs decreased overall but did not affect the ranking of the most cost-effective strategy. While a 5-yearly interval became more cost-effective than a 3-yearly interval. Including HPV self-collection for under-screened women made all strategies more cost-effective. Interpretation: At current cervical screening participation (43.7%) and low vaccination coverage (<1.0%), HPV testing distinguishing HPV16/18 with reflex LBC (3-yearly) would be the most cost-effective screening strategy compared to conventional cytology (2-yearly). Funding: Grants-in-Aid for Scientific Research from the Japan Society for the Promotion of Science (17H03589) and Grants of the National Cancer Center Japan (Gan Kenkyu Kaihatsuhi 31-A-20 and 2023-A-23).

Frequent screening for asymptomatic chlamydia and gonorrhoea infections in men who have sex with men: time to re-evaluate?

There is increasing debate regarding the harms and benefits of frequent asymptomatic screening for Chlamydia trachomatis and Neisseria gonorrhoeae in men who have sex with men (MSM). One concern is that frequent asymptomatic screening could result in increased antimicrobial resistance in an array of sexually acquired infections and other pathogens, due to selection pressure exerted by frequent broad-spectrum antimicrobial usage within some sexual networks. Here, we outline the harms and benefits of frequent C trachomatis and N gonorrhoeae screening in MSM in high-income settings and propose that screening frequency be reduced. We describe the evidence gaps that should be further explored to better understand the implications of reducing the frequency of asymptomatic C trachomatis and N gonorrhoeae screening in MSM and the surveillance systems that should be in place to prepare for such changes.

Genotype prevalence and age distribution of human papillomavirus from infection to cervical cancer in Japanese women: A systematic review and meta-analysis.

BACKGROUND: National HPV vaccination coverage in Japan is less than one percent of the eligible population and cervical cancer incidence and mortality are increasing. This systematic review and meta-analysis aimed to provide a comprehensive estimate of HPV genotype prevalence for Japan. METHODS: English and Japanese databases were searched to March 2021 for research reporting HPV genotypes in cytology and histology samples from Japanese women. Summary estimates were calculated by disease stage from cytology only assessment - Normal, ASCUS, LSIL, HSIL and from histological assessment - CIN1, CIN2, CIN3/AIS, ICC (ICC-SCC, and ICC-ADC), and other. A random-effects meta-analysis was used to calculate summary prevalence estimates of any-HPV, high-risk (HR) and low-risk (LR) vaccine types, and vaccine genotypes (bivalent, quadrivalent, or nonavalent). This study was registered with PROSPERO: CRD42018117596. RESULTS: A total of 57759 women with normal cytology, 1766 ASCUS, 3764 LSIL, 2017 HSIL, 3130 CIN1, 1219 CIN2, 869 CIN3/AIS, and 4306 ICC (which included 1032 ICC-SCC, and 638 ICC-ADC) were tested for HPV. The summary estimate of any-HPV genotype in women with normal cytology was 15·6% (95% CI: 12·3-19·4) and in invasive cervical cancer (ICC) was 85·6% (80·7-89·8). The prevalence of HR-HPV was 86·0% (95% CI: 73·9-94·9) for cytological cases of HSIL, 76·9% (52·1-94·7) for histological cases of CIN3/AIS, and 75·7% (68·0-82·6) for ICC. In women with ICC, the summary prevalence of bivalent vaccine genotypes was 58·5% (95% CI: 52·1-64·9), for quadrivalent genotypes was 58·6% (52·2-64·9) and for nonavalent genotypes was 71·5% (64·9-77·6), and of ICC cases that were HPV positive over 90% of infections are nonavalent vaccine preventable. There was considerable heterogeneity in all HPV summary estimates and for ICC, this heterogeneity was not explained by variability in study design, sample type, HPV assay type, or HPV DNA detection method, although studies published in the 1990s had lower prevalence estimates of any-HPV and HR HPV genotypes. INTERPRETATIONS: HPV prevalence is high among Japanese women. The nonavalent vaccine is likely to have the greatest impact on reducing cervical cancer incidence and mortality in Japan.

Telehealth for sexual and reproductive health issues: a qualitative study of experiences of accessing care during COVID-19.

BACKGROUND: Medicare, the health insurance system underpinning free healthcare in Australia, introduced free telehealth items in 2020 in response to the coronavirus disease 2019 (COVID-19) pandemic. Their uptake among healthcare providers was significant, including among general practitioners and sexual health services. Here, we report people's experiences of accessing sexual and reproductive health (SRH)-related care via telehealth collected as part of a survey exploring the impact of COVID on SRH health. METHODS: This study utilises qualitative data from two online surveys conducted in 2020. Surveys were advertised through social media and professional and personal networks. Anyone aged≥18years and living in Australia was eligible to participate. Respondents were asked whether they accessed care for their SRH via telehealth. A free-text question asking for further detail about their experience was analysed using content analysis. RESULTS: A total of 114/1070 respondents (10.7%) accessed healthcare services via telehealth for SRH-related reasons within the previous 4weeks. Three themes were identified from 78 free-text comments: (1) accessibility and convenience of telehealth; (2) appropriateness of telehealth for SRH issues; and (3) connecting and communicating with clinicians via telehealth. Respondents had a wide range of experiences. Telehealth improved access to services for some participants, and it was appropriate for some, but not all SRH issues. Difficulties connecting with clinicians on both an interpersonal and technical level was a key barrier to a satisfactory patient experience. CONCLUSIONS: Telehealth can offer a viable alternative to face-to-face care, providing patients can overcome key connection and communication barriers.

‘I didn’t want to visit a doctor unless it was extremely necessary’: perspectives on delaying access to sexual and reproductive health care during the COVID-19 pandemic in Australia from an online survey.

Australians were subject to a series of COVID-19 lockdown restrictions throughout 2020. Although accessing medical care was allowable, concerns were raised that people were avoiding healthcare services. We explored young Australians' reasons for delaying seeking sexual and reproductive health (SRH) care during the pandemic, using data from two cross-sectional surveys. The surveys included a question asking whether respondents had delayed accessing care during the pandemic. Free-text responses from young Australians (aged 18-29 years) were analysed using conventional content analysis. In all, 1058 under-30s completed a survey, with 262 (24.8%) reporting they had delayed seeking SRH care. Of these, 228 (87.0%) respondents provided a free-text comment. Participants who commented were predominantly female (86.4%) and had a median age of 23 years (interquartile range 20-26 years). Most commonly, respondents delayed testing for sexually transmissible infections, cervical cancer screening, and contraceptive care. Some delayed accessing care despite experiencing symptoms. Participants avoided seeking care due to concerns about contracting COVID-19, uncertainty about accessing care during restrictions and anxiety relating to accessing SRH care. Although some reported a reduced need for SRH care, others required but did not access care. Young people should be reassured that SRH issues are a valid reason to access services, especially when experiencing symptoms.

Intensified partner notification and repeat testing can improve the effectiveness of screening in reducing Chlamydia trachomatis prevalence: a mathematical modelling study.

BACKGROUND: The Australian Chlamydia Control Effectiveness Pilot (ACCEPt) was a cluster randomised controlled trial designed to assess the effectiveness of annual chlamydia testing through general practice in Australia. The trial showed that testing rates increased among sexually active men and women aged 16-29 years, but after 3 years the estimated chlamydia prevalence did not differ between intervention and control communities. We developed a mathematical model to estimate the potential longer-term impact of chlamydia testing on prevalence in the general population. METHODS: We developed an individual-based model to simulate the transmission of Chlamydia trachomatis in a heterosexual population, calibrated to ACCEPt data. A proportion of the modelled population were tested for chlamydia and treated annually at coverage achieved in the control and intervention arms of ACCEPt. We estimated the reduction in chlamydia prevalence achieved by increasing retesting and by treating the partners of infected individuals up to 9 years after introduction of the intervention. RESULTS: Increasing the testing coverage in the general Australian heterosexual population to the level achieved in the ACCEPt intervention arm resulted in reduction in the population-level prevalence of chlamydia from 4.6% to 2.7% in those aged 16-29 years old after 10 years (a relative reduction of 41%). The prevalence reduces to 2.2% if the proportion retested within 4 months of treatment is doubled from the rate achieved in the ACCEPt intervention arm (a relative reduction of 52%), and to 1.9% if the partner treatment rate is increased from 30%, as assumed in the base case, to 50% (a relative reduction of 59%). CONCLUSION: A reduction in C. trachomatis prevalence could be achieved if the level of testing as observed in the ACCEPt intervention arm can be maintained at a population level. More substantial reductions can be achieved with intensified case management comprising retesting of those treated and treatment of partners of infected individuals.

Rectal chlamydia infections: implications for reinfection risk, screening, and treatment guidelines.

PURPOSE OF REVIEW: Rectal chlamydia is a prevalent sexually transmissible infection in both men who have sex with men (MSM) and in women. Screening is recommended for MSM but remains controversial for women. The optimal treatment for rectal chlamydia is now conclusive but interpreting and managing positive results remains challenging. Infections among MSM are increasing and strategies are needed to reduce incident infections. This review summarizes recent developments for the screening and management of rectal chlamydia and its implications on reinfection. RECENT FINDINGS: Reinfections in MSM may be occurring due to resumption of sex soon after treatment whereas repeat infections in women may occur due to autoinoculation in the absence of sex. Doxycycline is now first-line treatment but its role in chemoprophylaxis remains unclear. False positive results remain an issue, but the development of viability assays may prove useful in future to determine true infections. SUMMARY: Doxycycline is the first-line treatment for rectal chlamydia and in women may prevent infections at the urogenital site. Viability assays can help to reduce antibiotic use once developed. The role of routine screening of rectal chlamydia in women remains unclear and this debate may soon include asymptomatic infections in MSM.

Accuracy of Self-reported Human Papillomavirus Vaccination Status Among Gay and Bisexual Adolescent Males: Cross-sectional Study.

BACKGROUND: Men who have sex with men are a risk group for anal human papillomavirus (HPV) and anal cancer. Australia introduced a universal school-based HPV vaccination program in 2013. Self-reported HPV vaccination status has been widely used in clinical and research settings, but its accuracy is understudied. OBJECTIVE: We aimed to examine the accuracy of self-reported HPV vaccination status among gay and bisexual adolescent males. METHODS: We included 192 gay and bisexual males aged 16-20 years from the Human Papillomavirus in Young People Epidemiological Research 2 (HYPER2) study in Melbourne, Australia. All participants had been eligible for the universal school-based HPV vaccination program implemented in 2013 and were asked to self-report their HPV vaccination status. Written informed consent was obtained to verify their HPV vaccination status using records at the National HPV Vaccination Program Register and the Australian Immunisation Register. We calculated the sensitivity, specificity, positive predictive value, and negative predictive value of self-reported HPV vaccination status. RESULTS: The median age of the 192 males was 19 (IQR 18-20) years. There were 128 males (67%) who had HPV vaccination records documented on either registry. Self-reported HPV vaccination had a sensitivity of 47.7% (95% CI 38.8%-56.7%; 61/128), a specificity of 85.9% (95% CI 75.0%-93.4%; 55/64), a positive predictive value of 87.1% (95% CI 77.0%-93.9%; 61/70), and a negative predictive value of 45.1% (95% CI 36.1%-54.3%; 55/122). CONCLUSIONS: Self-reported HPV vaccination status among Australian gay and bisexual adolescent males underestimates actual vaccination and may be inaccurate for clinical and research purposes.

Human papillomavirus prevalence and risk factors among Australian women 9-12 years after vaccine program introduction.

BACKGROUND: In Australia, high and widespread uptake of the quadrivalent human papillomavirus (HPV) vaccine has led to substantial population-level reductions in the prevalence of quadrivalent vaccine targeted HPV genotypes 6/11/16/18 in women aged ≤ 35 years. We assessed risk factors for HPV detection among 18-35 year old women, 9-12 years after vaccine program introduction. METHODS: Women attending health services between 2015 and 2018 provided a self-collected vaginal specimen for HPV genotyping (Roche Linear Array) and completed a questionnaire. HPV vaccination status was validated against the National Register. Adjusted odds ratios (aORs) and 95% confidence intervals (CI) were calculated for factors associated with HPV detection. RESULTS: Among 1564 women (median age 24 years; IQR 21-27 years), Register-confirmed ≥ 1-dose vaccine coverage was highest at 69.3% and 68.1% among women aged 18-21 and 22-24 years respectively, decreasing to 42.9% among those aged 30-35 years. Overall prevalence of quadrivalent vaccine-targeted HPV types was very low (2.0%; 95% CI: 1.4-2.8%) and influenced only by vaccination status (5.5% among unvaccinated compared with 0.7% among vaccinated women; aOR = 0.13 (95% CI: 0.05-0.30)). Prevalence of remaining HPV types, at 40.4% (95% CI: 38.0-42.9%), was influenced by established risk factors for HPV infection; younger age-group (p-trend < 0.001), more recent (p < 0.001) and lifetime sexual partners (p-trend < 0.001), but not vaccination status. Prevalence of HPV31/33/45, which shared risk factors with that of non-vaccine targeted HPV types, was also lower among vaccinated (4%) compared with unvaccinated (7%) women (aOR = 0.51; 95% CI: 0.29-0.89), indicative of cross-protection. CONCLUSION: Vaccination has changed the epidemiology of HPV infection in Australian women, having markedly reduced the prevalence of vaccine-targeted types, including amongst women with known risk factors for infection. Vaccinated women appear to be benefiting from modest cross-protection against types 31/33/45 afforded by the quadrivalent HPV vaccine. These results reinforce the importance of HPV vaccination.

Chlamydial clinical isolates show subtle differences in persistence phenotypes and growth in vitro.

Urogenital Chlamydia trachomatis infection is the most common sexually transmitted bacterial infection throughout the world. While progress has been made to better understand how type strains develop and respond to environmental stress in vitro, very few studies have examined how clinical isolates behave under similar conditions. Here, we examined the development and persistence phenotypes of several clinical isolates, to determine how similar they are to each other, and the type strain C. trachomatis D/UW-3/Cx. The type strain was shown to produce infectious progeny at a higher magnitude than each of the clinical isolates, in each of the six tested cell lines. All chlamydial strains produced the highest number of infectious progeny at 44 h post-infection in the McCoy B murine fibroblast cell line, yet showed higher levels of infectivity in the MCF-7 human epithelial cell line. The clinical isolates were shown to be more susceptible than the type strain to the effects of penicillin and iron deprivation persistence models in the MCF-7 cell line. While subtle differences between clinical isolates were observed throughout the experiments conducted, no significant differences were identified. This study reinforces the importance of examining clinical isolates when trying to relate in vitro data to clinical outcomes, as well as the importance of considering the adaptations many type strains have to being cultured in vitro.

Prevalence of human papillomavirus in young men who have sex with men after the implementation of gender-neutral HPV vaccination: a repeated cross-sectional study.

BACKGROUND: Anal infection with high-risk human papillomavirus (HPV) genotypes 16 and 18 and anal cancer are overrepresented in men who have sex with men (MSM). This study investigated HPV prevalence in young MSM before and after the implementation of a school-based quadrivalent HPV (genotypes 6, 11, 16, and 18) vaccination programme for boys in Australia in 2013. METHODS: In this repeated cross-sectional study, MSM aged 16-20 years were recruited from two successive birth cohorts via sexual health clinics and the community in Melbourne, Australia. The first cohort was before the implementation of gender-neutral vaccination (HYPER1 study, done in 2010-12, NCT01422356), and the second was the post-vaccination cohort (HYPER2 study, done in 2017-18, NCT03000933). Men who self-identified as being same-sex attracted were enrolled, and those recruited via the HYPER2 study had to be resident in Australia since 2013 to ensure eligibility. Study procedures were done in the Melbourne Sexual Health Centre. A clinician-collected anal swab and self-collected penile swab and oral rinse were tested for 28 HPV genotypes, and data on demographics and sexual health practices were collected via questionnaires. Only assessable samples were included in the analyses. We compared anatomical site-specific prevalence of HPV genotypes between cohorts by calculating the prevalence ratio, adjusting for age, circumcision, and sex with women. Herd protection was also assessed, by calculating the adjusted prevalence ratios by vaccination status. FINDINGS: 400 MSM, 200 per cohort, were included in the study. In both cohorts, the median number of lifetime male partners was ten (IQR 5-25). The prevalence of any anal quadrivalent vaccine-preventable HPV genotype was higher in the pre-vaccination cohort (54 [28%] of 193) than in the post-vaccination cohort (14 [7%] of 193; adjusted prevalence ratio [PR] 0·24, 95% CI 0·14-0·42), largely driven by decreases in HPV6, followed by HPV11, 16, and 18. Nevertheless, there was also a significant reduction in anal HPV16 and 18 in the post-vaccination cohort from the pre-vaccination cohort (0·31, 0·14-0·68). The prevalence of any penile quadrivalent vaccine-preventable HPV genotype was also higher in the pre-vaccination cohort (21 [12%] of 177) than in the post-vaccination cohort (11 [6%] of 179; 0·48, 0·24-0·97), driven by decreases in HPV 6 and 11, but not by 16 and 18. The prevalence of any oral quadrivalent vaccine-preventable HPV genotype was higher in the pre-vaccination cohort (seven [4%] of 200) than in the post-vaccination cohort (one [1%] of 199; 0·10, 0·01-0·97); there were no cases of oral HPV6 or 11 detected in HYPER2. Comparing the pre-vaccinated cohort with the 149 confirmed vaccinated men from HYPER2 showed a reduction in any quadrivalent vaccine-preventable HPV genotype for anal (0·09, 0·03-0·25) and penile (0·18, 0·05-0·59) infection but not for oral infection (0·17, 0·03-1·08). INTERPRETATION: A reduction in anal, penile, and oral quadrivalent vaccine-targeted genotypes occurred in young MSM following the implementation of a school-based gender-neutral HPV vaccination programme. The fall in anal HPV16 and 18 may lead to a reduction in the incidence of anal cancer. FUNDING: Merck and the Australian Government Department of Health.

Prevalence of sexually transmissible infections and HIV in men attending sex-on-premises venues in Australia: a systematic review and meta-analysis of observational studies.

Background In Australia, men who have sex with men (MSM) have high rates sexually transmissible infections (STIs) and sex-on-premises venue (SOPV) patrons are at risk. This paper assesses Neisseria gonorrhoeae (NG), Chlamydia trachomatis (CT), syphilis and HIV prevalence in men tested at Australian SOPVs and describes testing services. METHODS: EMBASE, Medline, PubMed and international conference proceedings were searched for articles reporting on-site SOPV testing between 1 January 2000 and 31 January 2017. Meta-analysis calculated pooled prevalence estimates of STIs by anatomical site. RESULTS: Twelve cross-sectional studies were identified. Most (8/12) were local sexual health clinics (SHC) outreach services. Participants' mean age was 41.1 years (95% confidence interval (CI) 37.0-43.3; range 17 to 84 years). Testing included CT and NG (9/12), HIV (8/12) and syphilis (5/12). CT and NG prevalence overall summary estimates were 3.4% (95% CI 1.9-5.2%, I2 = 88.7%, P < 0.01) and 1.3% (95% CI 0.7-2.2%, I2 = 75.5%, P < 0.01) respectively. CT and NG prevalence was highest in the ano-rectum and oro-pharynx respectively. The HIV and syphilis pooled estimates were 2.3% (95% CI 1.6-2.9%, I2 = 93.1%, P < 0.01) and 3.2% (95% CI 1.8-4.6%, I2 = 72.8%, P < 0.01) respectively. Participation rate varied. CONCLUSION: This review examines HIV and STI testing in Australian SOPVs before HIV pre-exposure prophylaxis (PrEP). Findings indicate a high prevalence of STIs. PrEP use and resultant condomless sex may influence STI prevalence. Further research is required to determine the effect of PrEP on the STI prevalence among SOPV patrons.

Monitoring human papillomavirus prevalence among young Australian women undergoing routine chlamydia screening.

INTRODUCTION: Australia has recently implemented major changes in cervical cancer prevention policies including introduction of primary human papillomavirus (HPV) screening starting at age 25, and replacement of the quadrivalent HPV vaccine with the nonavalent vaccine in the national school-based program. We assessed the feasibility and utility of conducting HPV testing in residual clinical specimens submitted for routine Chlamydia trachomatis screening, as a means of tracking HPV vaccine program impact among young sexually active women. METHODS: De-identified residual specimens from women aged 16-24 years submitted for chlamydia testing were collected from three pathology laboratories in Victoria and New South Wales. Limited demographic information, and chlamydia test results were also collected. Patient identifiers were sent directly from the laboratories to the National HPV Vaccination Program Register, to obtain HPV vaccination histories. Samples underwent HPV genotyping using Seegene Anyplex II HPV 28 assay. RESULTS: Between April and July 2018, 362 residual samples were collected, the majority (60.2%) of which were cervical swabs. Demographic data and vaccination histories were received for 357 (98.6%) women (mean age 21.8, SD 2.0). Overall, 65.6% of women were fully vaccinated, 9.8% partially, and 24.7% unvaccinated. The majority (86.0%) resided in a major city, 35.9% were classified in the upper quintile of socioeconomic advantage and chlamydia positivity was 7.8%.The prevalence of quadrivalent vaccine-targeted types (HPV6/11/16/18) was 2.8% (1.5-5.1%) overall with no differences by vaccination status (p = 0.729). The prevalence of additional nonavalent vaccine-targeted types (HPV31/33/45/52/58) was 19.3% (15.6-23.8%). One or more oncogenic HPV types were detected in 46.8% (95% CI 41.6-52.0%) of women. CONCLUSIONS: HPV testing of residual chlamydia specimens provides a simple, feasible method for monitoring circulating genotypes. Applied on a larger scale this method can be utilised to obtain a timely assessment of nonavalent vaccine impact among young women not yet eligible for cervical screening.

Supplemental Trichomonas vaginalis testing is required to maintain control following a transition from Pap smear to HPV DNA testing for cervical screening: a mathematical modelling study.

OBJECTIVES: Using mathematical modelling, we have previously shown that the prevalence of infection with Trichomonas vaginalis (TV) is likely to increase in the general population in Australia with the transition from Pap smear-based cervical screening to human papillomavirus (HPV) DNA testing. Here we use the existing model to estimate the level of supplemental testing required to maintain TV control. METHODS: A compartmental mathematical model describing the transmission of TV in the general heterosexual population in Australia was used to evaluate the impact of a range of screening scenarios on TV prevalence over time following the transition to HPV DNA testing for cervical screening. Scenarios considered were the inclusion of a TV test with the HPV test and the addition of TV testing to routine chlamydia testing conducted in primary care. RESULTS: Our modelling suggests that with sufficient coverage, inclusion of TV testing with routine chlamydia screening in general practice, TV prevalence can be reduced over time, but at the current reported coverage will gradually increase following the transition to HPV testing. Inclusion of TV testing with HPV testing in the cervical screening programme is preferable to no supplemental testing but is considerably less effective in controlling TV. CONCLUSIONS: These findings support the inclusion of TV testing with routine chlamydia testing of young people.

Gardnerella vaginalis Clade Distribution Is Associated With Behavioral Practices and Nugent Score in Women Who Have Sex With Women.

BACKGROUND: Gardnerella vaginalis is detected in women with and without bacterial vaginosis (BV). Identification of 4 G. vaginalis clades raised the possibility that pathogenic and commensal clades exist. We investigated the association of behavioral practices and Nugent Score with G. vaginalis clade distribution in women who have sex with women (WSW). METHODS: Longitudinal self-collected vaginal specimens were analyzed using established G. vaginalis species-specific and clade-typing polymerase chain reaction assays. Logistic regression assessed factors associated with detection of G. vaginalis clades, and multinomial regression assessed factors associated with number of clades. RESULTS: Clades 1, 2, and 3 and multiclade communities (<2 clades) were associated with Nugent-BV. Clade 1 (odds ratio [OR], 3.36; 95% confidence interval [CI], 1.65-6.84) and multiclade communities (relative risk ratio [RRR], 9.51; 95% CI, 4.36-20.73) were also associated with Lactobacillus-deficient vaginal microbiota. Clade 4 was neither associated with Nugent-BV nor Lactobacillus-deficient microbiota (OR, 1.49; 95% CI, 0.67-3.33). Specific clades were associated with differing behavioral practices. Clade 1 was associated with increasing number of recent sexual partners and smoking, whereas clade 2 was associated with penile-vaginal sex and sharing of sex toys with female partners. CONCLUSIONS: Our results suggest that G. vaginalis clades have varying levels of pathogenicity in WSW, with acquisition occurring through sexual activity. These findings suggest that partner treatment may be an appropriate strategy to improve BV cure.

Prevalence of human papillomavirus in teenage heterosexual males following the implementation of female and male school-based vaccination in Australia: 2014-2017.

BACKGROUND: Australia introduced a school-based human papillomavirus (HPV) vaccination program for females aged 12-13 years in 2007, with a three-year catch-up to age 26; and for boys aged 12-13 from 2013, with a two-year catch-up to age 15. This study aimed to compare the prevalence of penile HPV between teenage heterosexual males in cohorts eligible or non-eligible for the school-based male vaccination program. METHODS: Between 2014 and 2017, sexually active heterosexual males aged 17-19 were recruited from sexual health centres and community sources across Australia. Males provided a self-collected penile swab for 37 HPV genotypes using Roche Linear Array and completed a questionnaire. We calculated adjusted prevalence ratios (aPR) of HPV between males in two periods: 2014-2015 (preceding implementation of school-based male vaccination) and 2016-2017 (eligible for school-based male vaccination). Self-reported vaccine doses were confirmed with doses reported to the National HPV Vaccination Program Register. RESULTS: Overall, 152 males were recruited in 2014-2015 and 146 in 2016-2017. Numbers of female sex partners and condom use did not differ between the two periods. The prevalence of quadrivalent vaccine-preventable [4vHPV] genotypes (6/11/16/18) was low in both periods (2.6% [2014-15] versus 0.7% [2016-17]; p = 0.371; aPR 0.28 [95% CI: 0.03-2.62]). Compared with men in 2014-2015, men in 2016-2017 had a lower prevalence of any of the 37 HPV genotypes tested (21.7% versus 11.6%; aPR 0.62 [95% CI: 0.36-1.07]) and any of the 13 high-risk genotypes tested (15.8% versus 7.5%; aPR 0.59 [95% CI: 0.30-1.19]). Prevalence of low-risk HPV genotypes did not differ between the two periods. Of the males recruited in 2016-2017, 55% had received ≥1 vaccine dose. CONCLUSION: The prevalence of 4vHPV genotypes among teenage heterosexual males in both cohorts was low, presumably due to herd protection from the female-only vaccination program. Further studies are required to determine the impact of universal HPV vaccination on HPV prevalence in males.

Population effectiveness of opportunistic chlamydia testing in primary care in Australia: a cluster-randomised controlled trial.

BACKGROUND: Screening young adults who are sexually active for genital Chlamydia trachomatis infection is promoted in several high-income countries, but its effectiveness at the population level is highly debated. We aimed to investigate the effects of opportunistic chlamydia testing in primary care on the estimated chlamydia prevalence in the population aged 16-29 years in Australia. METHODS: We did a cluster-randomised controlled trial. Clusters were rural towns with a minimum of 500 women and men aged 16-29 years and no more than six primary care clinics. We randomly allocated each cluster using a computer-generated minimisation algorithm to receive a multifaceted, clinic-based chlamydia testing intervention or to continue usual care. The intervention included computerised reminders to test patients, an education package, payments for chlamydia testing, and feedback on testing rates. The primary outcome was chlamydia prevalence, estimated before randomisation (survey 1) and at the end of the trial (survey 2) in patients aged 16-29 years who attended the clinics. Analyses were done by intention to treat. General practitioners and clinic staff were aware of group allocation, whereas patients and laboratory staff who performed the chlamydia tests were not. This trial was completed on Dec 31, 2015, and is registered (ACTRN12610000297022). FINDINGS: Between Dec 14, 2010, and Sept 14, 2015, 26 clusters (63 clinics) received the chlamydia testing intervention and 26 (67 clinics) continued usual care. Over a mean duration of 3·1 years (SD 0·3), 93 828 young adults attended intervention clinics and 86 527 attended control clinics. The estimated chlamydia prevalence decreased from 5·0% (95% CI 3·8 to 6·2) at survey 1 to 3·4% (2·7 to 4·1) at survey 2 in the intervention clusters (difference -1·6%, 95% CI -2·9 to -0·3) and from 4·6% (95% CI 3·5 to 5·7) at survey 1 to 3·4% (2·4 to 4·5) at survey 2 in the control clusters (difference -1·1%, -2·7 to 0·5). The unadjusted odds ratio for the difference between intervention and control clusters was 0·9 (95% CI 0·5 to 1·5). INTERPRETATION: These findings, in conjunction with evidence about the feasibility of sustained uptake of opportunistic testing in primary care, indicate that sizeable reductions in chlamydia prevalence might not be achievable. FUNDING: Australian Government Department of Health, National Health and Medical Research Council, Victorian Department of Health and Human Services, and New South Wales Ministry of Health.

Chlamydia trachomatis and the risk of spontaneous preterm birth, babies who are born small for gestational age, and stillbirth: a population-based cohort study.

BACKGROUND: Chlamydia trachomatis is one of the most commonly diagnosed sexually transmitted infections worldwide, but reports in the medical literature of an association between genital chlamydia infection and adverse obstetric outcomes are inconsistent. METHODS: The Western Australia Data Linkage Branch created a cohort of women of reproductive age by linking records of birth registrations with the electoral roll for women in Western Australia who were born from 1974 to 1995. The cohort was then linked to both chlamydia testing records and the state perinatal registry for data on preterm births and other adverse obstetric outcomes. We determined associations between chlamydia testing, test positivity, and adverse obstetric outcomes using multivariate logistic regression analyses. FINDINGS: From 2001 to 2012, 101 558 women aged 15 to 38 years had a singleton birth. Of these women, 3921 (3·9%) had a spontaneous preterm birth, 9762 (9·6% of 101 371 women with available data) had a baby who was small for gestational age, and 682 (0·7%) had a stillbirth. During their pregnancy, 21 267 (20·9%) of these women had at least one chlamydia test record, and 1365 (6·4%) of those tested were positive. Before pregnancy, 19 157 (18·9%) of these women were tested for chlamydia, of whom 1595 (8·3%) tested positive for chlamydia. Among all women with a test record, after adjusting for age, ethnicity, maternal smoking, and history of other infections, we found no significant association between a positive test for chlamydia and spontaneous preterm birth (adjusted odds ratio 1·08 [95% CI 0·91-1·28]; p=0·37), a baby who was small for gestational age (0·95 [0·85-1·07]; p=0·39), or stillbirth (0·93 [0·61-1·42]; p=0·74). INTERPRETATION: A genital chlamydia infection that is diagnosed and, presumably, treated either during or before pregnancy does not substantially increase a woman's risk of having a spontaneous preterm birth, having a baby who is small for gestational age, or having a stillbirth. FUNDING: Australian National Health and Medical Research Council.

Impact of replacing cytology with human papillomavirus testing for cervical cancer screening on the prevalence of Trichomonas vaginalis: a modelling study.

OBJECTIVES: Trichomonas vaginalis (TV) is the most common curable STI worldwide and is associated with increased risk of HIV acquisition and serious reproductive morbidities. The prevalence of TV infection is very low in Australian cities, and this is thought to be at least partly due to incidental detection and treatment of TV in women participating in the cervical cytology screening programme. In 2017, the national cervical screening programme will transition to a new model based on testing for high-risk (HR) human papillomavirus (HPV), with a reduced frequency and commencement at an older age. We model the potential impact of this transition on TV prevalence in Australia. METHODS: A mathematical model was developed to describe the transmission of TV in the general population and used to evaluate scenarios that capture the switch from cytology-based screening to HR HPV testing. Under these scenarios, individuals with asymptomatic TV who test negative for HR HPV will remain undiagnosed and untreated. We estimate the change in TV prevalence expected to occur due to the switch from cytology to HR HPV testing and changes to the frequency and age at commencement of screening. RESULTS: Our results suggest that with the transition to HR HPV testing, TV prevalence may increase from the current ~0.4% to 2.8% within 20 years if TV testing coverage is not increased and HR HPV prevalence does not decline further. If HR HPV prevalence continues to decline at its current rate with ongoing vaccination, TV prevalence is predicted to increase to 3.0% within this time frame. CONCLUSIONS: Our modelling suggests that in a setting like Australia, where TV can be detected incidentally through cytology-based cervical screening, a transition to HPV testing is likely to result in increasing TV prevalence over time unless additional measures are implemented to increase TV testing and treatment.